Intrommune Therapeutics, a NYC-based biopharmaceutical company developing a patient-friendly immunotherapy platform for the treatment of food allergies, submitted its request for a Pre-IND meeting with the FDA to review its first product candidate, INT301. INT301 is an oral mucosal immunotherapy (OMIT) product for the long-term treatment of peanut allergy using a patent-protected therapeutic delivered while a patient brushes their teeth. The company is looking forward to collaborating with the FDA.

Michael Nelson, CEO at Intrommune stated, “There are currently no market approved treatments for food allergy. We are excited to be working with the FDA and look forward to discussing INT301, our oral mucosal immunotherapy product candidate for peanut allergies, and working towards testing its safety and efficacy in the clinical setting.”

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational biological product to humans. The Pre-IND meeting provides an opportunity for open collaboration between Intrommune Therapeutics and the FDA to review INT301, planned IND content, and the investigational plan for our licensing application.

Anthony Robinson, COO adds, “The submission of this request is the result of substantial effort over the past two years and collaboration with our advisors including top food allergy experts to develop protocols that are safe and satisfy FDA requirements, while meeting the needs of patients. Intrommune continues to meet its targets and is on track to file for investigational new drug (IND) review and approval in 2018 for INT301 with the FDA. We anticipate that INT301 will be a major advancement in the long-term treatment of peanut allergies. It is appropriate that we reach this first step and milestone during Food Allergy Awareness Week.”

Intrommune Therapeutics crowdfunding financing campaign on the Netcapital platform is intended to support the next steps of development for INT301, including preparation for the pre-IND meeting. Over the past two years, Intrommune Therapeutics has locked down the OMIT intellectual property portfolio and laid the groundwork for a research program to support the development of INT301. Every investment in Intrommune Therapeutics will help us reach our goal of bringing this potentially life altering allergy immunotherapy closer to development while providing investors the opportunity to make substantial returns if our efforts are successful.

Oral mucosal immunotherapy (OMIT) uses a specially formulated toothpaste to stabilize and deliver allergenic proteins to immunologically active areas of the oral cavity with the greatest potential for allergy desensitization. Success with allergy immunotherapy hinges on consistent exposure of a patient’s immune system to gradually “desensitize” the patient to the specific allergy trigger over time. OMIT promises advantages over other approaches to allergy immunotherapy due to its targeted delivery, simplified administration, and support of reliable, long-term adherence.

About Intrommune Therapeutics

Intrommune is developing the revolutionary oral mucosal immunotherapy (OMIT) treatment platform for food allergies. OMIT is a long-term, patient-friendly, disease-modifying solution for the 220 million people, including 9 million adults and 6 million children in the U.S., who suffer from life-altering food allergies. Intrommune’s lead product, INT301, is expected to be a safe, effective and convenient therapy for patients who suffer from peanut allergy. There is no FDA-approved treatment for peanut allergy or any other food allergy.

This release may contain "forward-looking statements". Forward-looking statements are identified by certain words or phrases such as "may", "will", "aim", "will likely result", "believe", "expect", "will continue", "anticipate", "estimate", "intend", "plan", "contemplate", "seek to", "future", "objective", "goal", "project", "should", "will pursue" and similar expressions or variations of such expressions. These forward-looking statements reflect the company's current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the company. The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.

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